Bowel Preparation Before Three-dimensional Rectal Water Contrast Transvaginal Ultrasonography for Diagnosing the Presence and Describing the Characteristics of Rectosigmoid Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the accuracy of 3D-RWC-TVS with and without bowel preparation in the diagnosis of rectosigmoid endometriosis.
研究概览
简要总结
Three-dimensional (3D) rendering may be employed during transvaginal rectal water-contrast transvaginal ultrasonography (RWC-TVS) for detecting the presence and describe the characteristics of rectosigmoid endometriosis. This study aims to evaluate the impact of bowel preparation on the diagnostic parameters of 3D-RWC-TVS in women with suspicion of rectosigmoid endometriosis.
详细描述
An accurate diagnosis of the presence, location and extent of the rectosigmoid endometriosis is of paramount importance for the clinicians in order to inform the patients on the potential surgical or medical treatments. It is well established that transvaginal ultrasonography is the first-line investigation in patients with suspicion of deep infiltrating endometriosis. An improvement in the performance of transvaginal ultrasonography in diagnosing rectosigmoid endometriosis may be obtained by using rectal water contrast during transvaginal ultrasonographic scan. In the last years, three-dimensional (3D) rendering has been employed during transvaginal ultrasound for benign gynecological diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pain and intestinal symptoms suggestive of rectosigmoid endometriosis
排除标准
- •previous surgical diagnosis of intestinal endometriosis
- •previous radiological diagnosis of intestinal endometriosis (based on Magnetic Resonance or double-contrast barium enema
- •history of colorectal surgery (except appendectomy)
- •contraindications to bowel preparation or computed colonography (such as non-- compliant patients and rectal malformations)
- •previous bilateral ovariectomy
- •psychiatric disorders
结局指标
主要结局
To compare the accuracy of 3D-RWC-TVS with and without bowel preparation in the diagnosis of rectosigmoid endometriosis.
时间窗: At maximum 6 months before laparoscopic surgical approach
The results of imaging will be compared with surgical and histological findings.
次要结局
- To compare the precision of 3D-RWC-TVS with and without bowel preparation in estimating the length (mid-sagittal diameter) of the rectosigmoid endometriotic nodules(At maximum 6 months before laparoscopic surgical approach)
- To compare the accuracy of 3D-RWC-TVS with and without bowel preparation in the diagnosis of multifocal rectosigmoid endometriosis.(At maximum 6 months before laparoscopic surgical approach)
研究者
Simone Ferrero
Principal Investigator
Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia